Health conditions
(Data source: WHO)
Crohn's Disease (CD)
MedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Interventions (Data source: WHO)
Product Name: Upadacitinib
Product Code: ABT-494
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Upadacitinib
CAS Number: 1310726-60-3
Other descriptive name: ABT-494
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 45-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: Upadacitinib
Product Code: ABT-494
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Upadacitinib
CAS Number: 1310726-60-3
Other descriptive name: ABT-494
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Inclusion/Exclusion Criteria
(Data source: WHO)
Inclusion criteria:
- Confirmed diagnosis of CD for at least 3 months prior to Baseline.
- Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF), abdominal pain (AP) score.
- Evidence of mucosal inflammation based on the Simplified Endoscopic Score for Crohn's disease (SES-CD) on an endoscopy confirmed by a central reader.
- Demonstrated an inadequate response or intolerance to any biologic therapy for infliximab, adalimumab, certolizumab, pegol, vedolizumab, and ustekinumab.
- If female, subject must meet the contraception recommendations
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 613
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 32
Exclusion criteria:
- Participant with a current diagnosis of ulcerative colitis or indeterminate colitis.
- Participant not on stable doses of CD related antibiotics, oral aminosalicylates, corticosteroids or methotrexate (MTX).
- Participant with the following known complications of CD: abscess (abdominal or peri-anal), symptomatic bowel strictures, > 2 missing segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum; fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.
- Participant with ostomy or ileoanal pouch
- Participant diagnosed with short gut or short bowel syndrome
- Screening laboratory and other analyses show abnormal results.
-
Further information on trial
Date trial registered
Mar 12, 2018
Incorporation of the first participant
May 10, 2018
Recruitment status
Not Recruiting
Academic title
(Data source: WHO)
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy
Type of trial
(Data source: WHO)
Interventional clinical trial of medicinal product
Design of the trial
(Data source: WHO)
Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: no
Other: yes
Other trial design description: Part 1 Randomized, double-blind 2arm Part 2 Open Label 1arm Part 3 Extension Treatment Period 3arm
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
Phase
(Data source: WHO)
Human pharmacology (Phase I): noTherapeutic exploratory (Phase II): noTherapeutic confirmatory - (Phase III): yesTherapeutic use (Phase IV): no
Primary end point
(Data source: WHO)
Main Objective: The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in subjects with moderately and severely active Crohn's disease (CD).;Secondary Objective: To evaluate improvements in several efficacy parameters, including steroid discontinuation, laboratory parameters and quality of life questionnaires.;Primary end point(s): Co-primary Endpoints:
1. Proportion of subjects with clinical remission per PROs at Week 12
2. Proportion of subjects with endoscopic response at Week 12
;Timepoint(s) of evaluation of this end point: Week 12
Secundary end point
(Data source: WHO)
Secondary end point(s): 1. Proportion of subjects with clinical remission per CDAI (CDAI < 150)
2. Proportion of subjects with clinical remission at Week 4
3. Proportion of subjects with endoscopic remission at Week 12
4. Proportion of subjects who discontinue corticosteroid use for CD and achieve clinical remission at Week 12, in subjects taking
corticosteroids for CD at Baseline
5. Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue at Week 12
6. Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 12
7. Proportion of subjects achieving CR-100 at week 2
8. Proportion of subjects achieving CR-100 at week 12
9. Proportion of subjects with hospitalizations due to CD at during the 12 week double-blind induction period
10. Proportion of subjects with resolution of extra-intestinal manifestation (EIM) at Week 12, in subjects with EIM at Baseline.
;Timepoint(s) of evaluation of this end point: 1. week 12
2. week 4
3. week 12
4. week 12
5. week 12
6. week 12
7. week 2
8. week 12
9. week 12
10. week 12
Contact information
(Data source: WHO)
AbbVie Inc.
Trial results
(Data source: WHO)
Results summary
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or are Intolerant to Biologic Therapy
Link to the results in the primary register
no information available yet
Information on the availability of individual participant data
no information available yet
Trial sites
Countries
(Data source: WHO)
Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Germany, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Korea, Latvia, Lithuania, Malaysia, Mexico, Poland, Portugal, Puerto Rico, Republic of, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States
Contact for further information on the trial
Contact for general information
(Data source: WHO)
EU Clinical Trials Helpdesk
AbbVie House, Vanwall Business Park, Vanwall Road
AbbVie Ltd
+441628561090
eu-clinical-trials@abbvie.com
Contact for scientific information
(Data source: WHO)
EU Clinical Trials Helpdesk
AbbVie House, Vanwall Business Park, Vanwall Road
AbbVie Ltd
+441628561090
eu-clinical-trials@abbvie.com
Further trial identification numbers
Secondary ID (Data source: WHO)
M14-431
2017-001226-18-SK
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